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Stability and Degradation Programs

Stability testing is used to demonstrate short and long term stability of a biologic after exposure to various environmental conditions such as temperature, humidity, light and container/closure interactions. Because of the sensitive composition of most biopharmaceuticals, evaluation of the stability of a drug substance and drug product is a necessary part of developing a licensed or registered product. We partner with you to develop stability protocols designed to meet product-specific needs and the requirements outlined by ICH. Data from these stability studies is used to recommend storage conditions, re-test intervals, and shelf-life.